Management of Biocide Applications: Processing and Screening

On this page

• Processing of an application
• Cancellation during the processing period
• Initial verification of a biocide application
• Screening of an application during the Screening 1 period
• Cancellation during the Screening 1 period
• Issuance of Screening Acceptance Letter (SAL)
• Solicited information during the Screening 1 period

Processing of an application

All biocide applications are subject to a 10-calendar day processing period following their receipt by Health Canada's Office of Submissions and Intellectual Property (OSIP) and prior to the screening of the application. The filing date will only be set once an application is considered to be administratively complete following the processing period.

During this processing period, OSIP completes the following activities, depending on the application type:

• assign a control number to the application
• enter initial information into the Biocides Tracking System (BTS) (e.g., active ingredient, physical form, brand name, date received)
• verify the information submitted to confirm that the application is administratively complete (e.g., to ensure that all necessary forms have been submitted, and cost recovery sections have been filled out).

At this stage in processing, if there are any administrative deficiencies the information package may be placed on Processing Hold. When the application is placed on Processing Hold, the filing date is not final. You will then receive an email acknowledging receipt of the application with the requested additional information and instructions to address the deficiencies. For example, this could occur when conflicting information is identified between the cover letter suggesting the filing intent differs from the Biocide Application Form (BAF). When submitting the requested information, select "Response to Processing Clarification Request" from the relevant regulatory activity types on the BAF. Once the requested information has been provided and is considered administratively complete, the processing hold is resolved. When the Processing Hold is resolved, the following occurs:

• The information package is considered administratively complete, it is assigned a filing date and becomes an application, and
• The application enters Screening with Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD)

Cancellation during the processing period

If you wish to cancel your application during the initial processing period, a letter requesting the cancellation should be sent to Health Canada (refer to filing of information to Health Canada).

You may cancel an application without having an impact on refiling.

Initial verification of a biocide application

When a biocide application is received by NNHPD, we conduct an initial verification to ensure that:

• the application pathway is correct based on the reason for filing
• the required information for the type of the application has been provided, and
• the fee is appropriate for the application

Details on Screening 1 are provided in this section. For more information on Review 1, refer to the Review section.

Screening of an application during the Screening 1 period

For the following application pathways, NNHPD completes the entire assessment during the Screening 1 period:

• Monograph
• Comparison – administrative
• Major change – monograph
• Major change – quality and risks
• Minor change
• Transition

For other application pathways, we conduct a 45-calendar day preliminary screen (i.e., Screening 1) before the application is accepted into Review 1. These include:

• full review (Tier I, Tier II, Tier III)
• full review - novel biocide
• comparison - labelling only
• use of foreign decisions (UFD)

We screen biocide applications within the performance standards specified for Screening 1 period in the performance standards for biocide applications table.

Cancellation during the Screening 1 period

If you wish to cancel your application during the Screening 1 period before it has been accepted into review (i.e., Review 1), a letter requesting the cancellation should be sent to Health Canada (refer to filing of information to Health Canada).

NNHPD will issue a cancellation acknowledgement letter.

You may cancel an application without having an impact on refiling.

To determine the fee that will be invoiced for a cancelled application, refer to the guidance on evaluation fees for biocides.

Issuance of Screening Acceptance Letter (SAL)

If the information you submitted is acceptable during the Screening 1 period and requests for information/clarification are not required (refer to the Clarification Requests during the Screening 1 Period section for more information), the application or response to solicited information is accepted into review (i.e., Review 1) and NNHPD will issue a Screening Acceptance Letter (SAL).

For applications that do not enter a Review 1 period, NNHPD will issue one of the following positive decisions at the completion of the screening:

• a market authorization containing the eight-digit identification number assigned to the biocide
• a No Objection Letter (NOL), for a minor change notification (refer to the No Objection Letter (NOL) section)

Solicited information during the Screening 1 period

Solicited information during the Screening 1 period is considered any information that is requested by NNHPD during the preliminary screening of an application. Examples include, but are not limited to, Clarification Requests and Screening Deficiency Notices (SDNs).

Clarification Request during the Screening 1 period

The purpose of a Clarification Request during the Screening 1 period is to seek clarification on specific information in the application before the application is accepted into review (i.e., Review 1). Clarification Requests are not issued during the Screening 1 period to request missing documents or data, but rather a Screening Deficiency Notice (SDN) would be issued.

For applications that do not enter a Review 1 period, the purpose of a Clarification Request is to seek clarification on specific information in the application regarding the biocide's risks, benefits, and any associated uncertainties (e.g., the safety, efficacy, and quality information). Examples of solicited information for these applications (for example, monograph applications) may include the submission of a scientific rationale, or changes to proposed labelling.

NNHPD will send clarification requests by email and the timeline to respond varies with the application pathway (refer to Time to respond to a clarification request).

To clarify points of the Clarification Request, or why we sent it, you should contact the sender of the request.

There is no limit on the number of Clarification Requests that NNHPD may send for one application. However, no particular issue will be addressed more than once.

Response to a Clarification Request during the Screening 1 period

When responding to a Clarification Request, you should clearly identify in the cover letter and the BAF:

• the name of the biocide
• the Dossier ID
• the control number of the relevant application
• the purpose of the correspondence (for example, "Response to a Screening Clarification Request")

Responses to Clarification Requests should be submitted in a question-and-answer format that references the applicable section(s) in the application (refer to Filing of information to Health Canada). A response is complete if all clarifications or questions identified in the Clarification Request have been addressed.

During the screening of an application, if NNHPD determines that a response to a Clarification Request is not satisfactory or is not submitted within the specified time to respond, we will send a Screening Deficiency Notice (SDN) or Screening Rejection Letter (SRL), as applicable. For more information, refer to the Screening Deficiency Notice and Screening Rejection Letter sections.

Screening Deficiency Notice (SDN) during the Screening 1 period

If NNHPD identifies deficiencies during the Screening 1 period, we will send you an SDN identifying the deficiencies. The status of the application will become inactive until your response is received. An SDN can be sent to you without prior issuance of a Clarification Request.

The solicited information is to be submitted to Health Canada within 45 calendar days from the date the SDN was sent.

To clarify points of the SDN or the rationale for its issuance, you should contact the sender of the notice.

Response to Screening Deficiency Notice (SDN) during the Screening 1 period

When responding to an SDN, you should clearly identify in the cover letter and the BAF:

• the name of the biocide
• the Dossier ID
• the control number of the relevant application
• the purpose of the correspondence (i.e., "Response to SDN")

The response should be submitted in a question-and-answer format that references the applicable section(s) of the application, as appropriate (refer to Filing of information to Health Canada.) The response to an SDN should not contain unsolicited information (refer to the Unsolicited information section).

You should send all requested information along with the up-to-date documents including an updated cover letter in a single package to OSIP for processing.

All administratively complete information received by OSIP will be processed and sent to NNHPD within 10 calendar days. Upon receipt of the information requested in the SDN, a new Screening 1 period will begin, and the requested material and information will be screened by NNHPD for completeness.

Acceptance letter following the response to a Screening Deficiency Notice (SDN)

If the response to the SDN is screened and found acceptable by NNHPD, we will send you a SAL and the review (i.e., Review 1) period will begin immediately (refer to the Issuance of Screening Acceptance Letter section).

For applications that do not enter a Review 1 period, NNHPD will issue one of the following positive decisions at the completion of the screening:

• a market authorization containing the eight-digit identification number assigned to the biocide
• a No Objection Letter (NOL), for a minor change notification (refer to the No Objection Letter (NOL) section)

Screening Rejection Letter (SRL)

We will send you an SRL if you fail to provide a response to the SDN within the assigned time period or if the information submitted is incomplete, deficient or contains unsolicited information.

To clarify points of the SRL or why we sent it, you should contact NNHPD by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

If an SRL has been issued, you may refile the application without prejudice.

You may file a Request for Reconsideration following the issuance of a SRL (refer to the Reconsideration of decisions issued for biocide applications section).